Anyone who has an illness or health issue, with no apparent cure, is very vulnerable to treatments such as stem cells that have not been proven and which could in fact be dangerous. Those of us with Lymphedema fall into that category. There is some confusion around this treatment and I was very glad to find this website which has clear easily understood explanations of what is happening with Stem Cells… Also how to identify medical centres promoting unproven treatments…although referring to Australia this information forms a basis for all other countries.
Features of unproven stem cell treatments…..
Unproven stem cell treatments are those where doctors offer to treat patients without first properly evaluating the proposed treatment, effectively circumventing the clinical trial process.
Unlike the careful pace of legitimate preclinical and clinical stem cell research (as explained above), the doctors offering unproven stem cell treatments are effectively selling hope with little or no medical or scientific evidence to back up their claims around both safety and actual benefit. These unproven, highly experimental treatments also are not cheap, with prices ranging from $9,000 to $60,000 per treatment, and patients are often encouraged to consider multiple treatments.
Having heard about stem cells and the promises that these cells may hold for regenerative medicine, for many Australians it is difficult to recognise that the treatment is unproven. Many of these services are promoted on very impressive websites, with persuasive patient and/or carer testimonials supporting the benefit of the treatment. However there are some simple points to consider which will help you to identify providers of unproven stem cell treatments…..
Points to check if Stem cell treatment is unproven….
1 Scientific rationale is not made clear
2 Evidence of safety and efficacy in preclinical (animal) models is not provided or referenced
3 Treatment plan has not been peer-reviewed by an Ethics Committee
4 Payment is required
5 Benefit the practitioner (financially) and the patient (possibly)
6 Offered to patients who feel they have no other viable alternative
7 Offered by direct marketing (eg via the Internet) and often for a wide range of unrelated conditions
8 May be offered by doctors who are not experts in the condition being treated
9 May be performed at institutions with no track record of publications and research
10 Fully informed consent is often not obtained
11 Legal recourse if something goes wrong is often not clear
12 Medical insurance eligibility is often not clear
13 Limited or no long-term care or follow-up provided
For many years there has been concern about patients travelling overseas for unproven stem cell treatments that are not available here. Such travel is often referred to as stem cell tourism. However in recent years, there have been a growing number of Australian doctors and medical clinics offering unproven stem cell treatments here in Australia.
The fact that such treatments are being offered in Australia can make it more difficult to determine if the stem cell treatments are legitimate. Especially when the treatments use your cells.
Despite the exacting standards usually imposed by the Therapeutic Goods Administration (the TGA – which is the Australian regulator of all medical devices, drugs and biologicals), there is currently a controversial loophole in our Australian regulations. This means that unproven stem cell treatment is excluded from the regulatory framework provided the treatment is being offered by a registered Australian doctor, is using the patient’s own cells and is a one-patient treatment. It is not a requirement that such treatments have to be first proven safe and effective in clinical trials.
The treatments using the patient’s own cells are often marketed as having ‘no risks’ and are ‘natural’ because the cells come from you (ie are autologous). It is important for you to know that even treatments using your own cells can be dangerous. There have been reports of cells from fat growing into bone, as well as deaths reported overseas.
When deciding on what is best for you, not compromising the health that you do have, is an important consideration. Excerpt taken from the The Australian Stem Cell Handbook… http://www.stemcellfoundation.net.au/patient-information/handbook
With Thanks for their work in de-mystifying this area…